Recall Number,Trade Name/Product,Recall Class,Date Posted,Recalling Manufacturer,Reason for Recall
Z-0821-2014,Puritan Bennett 840 Series Ventilator - Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.,2,Jan-24-2014,Nellcor Puritan Bennett Inc. (dba Covidien LP),Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor); PN 4-072214-00 used in the Puritan Bennett" 840; and PN; G-062010-00; used in Puritan Bennett" 740; and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.
Z-0822-2014,Puritan Bennett 700 Series Ventilators (PB740 and PB760) - Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.,2,Jan-24-2014,Nellcor Puritan Bennett Inc. (dba Covidien LP),Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor); PN 4-072214-00 used in the Puritan Bennett" 840; and PN; G-062010-00; used in Puritan Bennett" 740; and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.